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FDA Inspection
•Saint Joseph Hospital•November 14, 2016

Saint Joseph Hospital – FDA Inspection, Nov 14, 2016

Record Details

This FDA Inspection record concerns Saint Joseph Hospital, with an inspection on November 14, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Saint Joseph Hospital
Inspection Date
November 14, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Grace P. Santos (Issuing Officer)
  • Laurissa S. Flowers (Issuing Officer)
View Company Profile

ID · 1be8948b-e2d4-4c5e-9d8c-71666f6a9a45

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
991905
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 606.160(a)(1)Concurrent documentation
  2. 21 CFR 606.160(a)(1)Person performing, test results, interpretation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Saint Joseph Hospital

5
DateClassificationOfficeProject area
October 17, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 26, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 15, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 8, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
December 19, 2008NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Saint Joseph Hospital
  • FDA Inspection 1070942 - 2018-10-17
  • FDA Inspection 925936 - 2015-02-26
  • FDA Inspection 822366 - 2013-03-15
  • FDA Inspection 727493 - 2011-06-08
  • FDA Inspection 553228 - 2008-12-19

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